St. Jude Medical ($STJ) gained a pivotal CE mark for two next-generation lines of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, advancing in Europe even as its rivals win U.S. approval for competing devices.
The European regulatory nod covers the company's Ellipse and SJM Assure ICDs and CRT-Ds, with some tweaks to improve the delivery of high voltage therapy and also reduce friction between the device and leads (a coating on the device). St. Jude touts the reduced friction in particular as a way to cut back on lead insulation failure rates--a sensitive spot for the company. St. Jude is confronting a number of lawsuits regarding its now-recalled Riata ICD leads, alleging they were poorly designed and made, leading to inappropriate shocks and device failure.
Concerns have also cropped up regarding St. Jude's Durata leads, which had been billed as a safer alternative. St. Jude continues to express confidence in the Durata leads, which it said will be used with the new Ellipse/SJM Assure products in Europe.
St. Jude's win in Europe comes as Germany's Biotronik and Medtronic ($MDT) have gained FDA sign-offs for new ICD and CRT-D devices, reflecting an aggressive move by the industry's major players to remain competitive in the cardiac rhythm management space despite ongoing sales struggles and pricing pressures. Hitting that point home, St. Jude experienced an 8% decline in its CRM unit during the fiscal 2013 first quarter, with a 5% drop in ICD sales and a 12% plunge in pacemaker revenue.
St. Jude hasn't forgotten the U.S. market. Last week the company announced it had launched an anticipated 500-patient study to test its Quadra Assura MP CRT-D in heart failure patients for whom existing therapies don't work well. That device already has a CE mark.
- here's the release